We are seeking a skilled Aseptic Operations Specialist to join our team. The successful candidate will be responsible for ensuring the smooth operation of our aseptic fill-finish equipment, while adhering to GMP and GDP standards.
Key Responsibilities:
* Perform routine maintenance and troubleshooting on aseptic fill-finish equipment, including compounding systems, filling lines, lyophilizers, cappers, inspection/packaging equipment, washers, and autoclaves.
* Troubleshoot mechanical, electrical, pneumatic, and control issues to minimize downtime and ensure compliance with regulatory requirements.
* Maintain and support critical utilities such as WFI, clean steam, compressed gases, HVAC, and environmental/room monitoring systems essential for aseptic operations.
Requirements:
* Bachelor's degree in Mechanical/Electrical/Automation/Industrial Maintenance or equivalent required.
* At least 2 years of experience in a cGMP environment within pharmaceutical, biotech, or aseptic fill-finish manufacturing.
Preferred Skills:
* Strong organizational, interpersonal, verbal, and written communication skills.
* Demonstrated ability to work independently or in a team, adapt to changing priorities, and contribute to a culture of continuous improvement.
Additional Information:
* This is a full-time position based in Tralee, Ireland.
* The ideal candidate will be willing to undertake international travel to vendor sites occasionally.